Job Listing Job ID: 12430797 Job Location: How to Apply: To see employer contact information, log in or register. Job Senior Regulatory Affairs Specialist - International - REMOTE Work Type: Work Days: Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular Salary Offered: Unspecified Benefits: Unspecified. Physical Required: Unspecified Drug Testing Required: Unspecified Education Required: Experience Required: Unspecified Required Skills: See Job Description section for any required skills. Job Description: Senior Regulatory Affairs Specialist - International - REMOTELocation:Rice Creek, Minnesota, United StatesRequisition #:2200050ZPost Date:5 days ago**SENIOR REGULATORY AFFAIRS SPECIALIST NEUROMODULATION, International**A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.Be part of work that matters. 75 million patients had their health improved by our products last year.Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapiesspan the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.**Careers that Change Lives**The **Senior Regulatory Affairs Specialist** is responsible for developing strategies for international governmental approval to introduce new products (Class III) to market, maintain existing products, provide advice on regulatory requirements, and prepare worldwide submissions.This position will support international regulatory activities associated with innovative devices. This opening is remote within the U.S.**A Day in the Life**Responsibilities may include the following and other duties may be assigned.+ Collaborate with the US Operating Unit Regulatory Affair team and international regulatory colleagues to provide regulatory support for new products/therapies or changes to existing products. Works with engineers and technical experts to address questions from regulatory agencies.+ Compile all materials required in new product submission, change submissions and license renewals for all regions other than US, EU and Canada.+ Maintains proficiency in worldwide regulatory requirements. Obtains and distributes updated information regarding worldwide laws, guidelines, and standards.+ Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.+ Collaborate with the US Operating Unit Regulatory Affair team to define global regulatory strategies and ensure international regulatory requirements are communicated to business teams.+ Provide feedback and ongoing support to product development teams for regulatory issues and questions.+ Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.+ Recommends changes for labeling, manufacturing, marketing, and the clinical protocol for regulatory compliance.+ Monitors and improves tracking/control systems.+ Recommends strategies for the earliest possible approvals of clinical trials applications.**Must Have: Minimum Requirements**+ Bachelors degree required with a minimum of 4 years of relevant experience+ OR an advanced degree with a minimum of 2 years of relevant experience**Nice to Have**+ Experience working with medical device or pharmaceutical regulatory submissions+ 7+ years medical device industry experience+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams+ Experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards+ Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).+ Experience with Class II/III medical devices (510(k), PMA, IDE)+ Experience with software development and cybersecurity applications+ Ability to comprehend principles of engineering, physiology and medical device use.+ Analytical thinking skills+ Ability to effectively manage multiple projects and priorities+ Proficient computer skills+ Project management skills+ Highly developed communication skills+ Effective interpersonal skills+ Clinical or statistical experience+ Medtronic product development experience**About Medtronic**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.**Physical Job Requirements**The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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